ambrisentan

Product NDC
50090-7671
11-digit product format
500907671
Labeler code
50090
Product ID
50090-7671_364758a6-9e0a-4ef9-8019-4bc320bdc9b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ambrisentan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA216531
Marketing category
ANDA
Marketing start
2022-07-21
Substance
AMBRISENTAN
Active strength
5 mg/1
Pharmacologic classes
Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
HW6NV07QECAMBRISENTAN177036-94-1AMBRISENTAN

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7671-05009076710030 TABLET, FILM COATED in 1 BOTTLE (50090-7671-0) 2025-10-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ambrisentanA-S Medication Solutions2025-10-08Human Prescription Drug Label1